📋 Quick Checklist Overview

This SOP covers:

• ✓ Patient intake and eligibility verification
• ✓ Documentation requirements and timeline
• ✓ Courier coordination and vetting
• ✓ Quality assurance and safety protocols
• ✓ Communication standards and touchpoints
• ✓ Troubleshooting and escalation procedures

When: First appointment or phone consultation

Responsible: Patient Coordinator

Actions:

• □ Confirm patient's permanent residence location
• □ Ask if patient plans to transfer embryos at another clinic
• □ Explain out-of-area patient process and timeline
• □ Provide cost estimate for embryo transport
• □ Set expectations for coordination requirements
• □ Document in patient record: "OUT-OF-AREA PATIENT"

When: During or immediately after IVF cycle

Responsible: Patient Coordinator + Patient

Actions:

• □ Patient selects destination clinic in their area
• □ Collect: Clinic name, address, phone, license number
• □ Identify destination clinic contact person (embryologist or lab director)
• □ Verify destination clinic will accept transferred embryos
• □ Confirm destination clinic's embryo acceptance policies

Required Documents:

• □ Embryo Release Authorization: Patient authorizes transfer to specific destination clinic
• □ Partner Consent (if applicable): If embryos created with partner, both parties must consent
• □ Courier Authorization: Permission for specific courier to take custody
• □ Acknowledgment of Risks: Patient understands transport process and rare risks
• □ Insurance and Liability: Patient acknowledges insurance coverage limits

Timeline: Collect at least 2 weeks before planned transfer date

Records to Prepare:

• □ IVF cycle summary (medications, doses, response)
• □ Egg retrieval report (number retrieved, maturity)
• □ Fertilization report (method, survival rates)
• □ Embryo development reports (day-by-day assessment)
• □ Cryopreservation records (method, date, embryologist notes)
• □ Genetic testing results (if PGT-A/PGS performed)
• □ Any prior transfer attempts at your clinic

Format: PDF package + paper copies for courier

Inventory Must Include:

• □ Total number of cryopreserved embryos
• □ Developmental stage of each (Day 3, Day 5, Day 6)
• □ Quality grades (using your clinic's grading system + explanation)
• □ Unique identifying numbers for each embryo
• □ Freeze dates for each embryo
• □ Cryopreservation method (slow freeze vs. vitrification)
• □ Storage container type (straws vs. vials)
• □ PGT-A status (tested, euploid/aneuploid, untested)

Verification: Senior embryologist must review and sign off on accuracy

Options:

• Patient selects: Patient chooses courier (subject to clinic approval per minimum standards)
• Clinic recommends: Provide 2-3 vetted courier options
• Clinic requires: Only specific approved couriers (if policy allows)

Minimum Courier Standards (Clinic Must Verify):

• □ Current IATA DGR certification (request copy)
• □ Minimum $5M liability insurance (request certificate)
• □ Hand-carry protocol (no cargo shipping)
• □ Temperature data logging capability
• □ Provide 3+ fertility clinic references
• □ GPS tracking available

Coordination Steps:

1. □ Confirm destination clinic's readiness date
2. □ Schedule courier pickup date (coordinate with destination clinic)
3. □ Provide courier with clinic hours and contact info
4. □ Confirm courier has proper dry shipper (validated and charged)
5. □ Schedule pickup time: Allow 30-60 minutes for verification process
6. □ Notify destination clinic of confirmed pickup date and expected delivery

Timeline: Schedule 2-4 weeks in advance for domestic; 8-12 weeks for international

QA Checklist:

• □ Locate embryos in storage tank (verify tank, cane, position)
• □ Confirm embryo labels match patient records
• □ Verify quantity matches inventory report
• □ Check storage tank temperature log (last 7 days)
• □ Photograph storage canes and labels (for records)
• □ Document any discrepancies immediately

Responsible: Senior embryologist

Packaging Checklist:

• □ Inspect dry shipper (if clinic-provided): No dents, holds temperature
• □ Verify dry shipper has 10+ days hold time remaining
• □ Prepare canes/canisters with clear labeling
• □ Include patient ID, number of embryos, clinic name
• □ Prepare all documentation (inventory, medical records, chain of custody forms)
• □ Seal documents in waterproof envelope

Upon Courier Arrival:

1. □ Verify courier identity (photo ID + company credentials)
2. □ Inspect dry shipper: Proper temperature, no damage, tamper-evident seals available
3. □ Review temperature monitoring system with courier
4. □ Confirm courier has all destination clinic contact information
5. □ Provide clinic emergency contact number

Verification Process:

1. □ Retrieve embryos from storage tank
2. □ Embryologist and courier jointly verify: Patient name/ID, Number of embryos, Label accuracy, Container type
3. □ Both parties sign verification form
4. □ Photograph embryo containers before packaging
5. □ Place embryos in dry shipper
6. □ Apply tamper-evident seal (record seal number)
7. □ Photograph sealed dry shipper

Final Steps:

• □ Provide courier with: Medical records package, Destination clinic contact info, Emergency contact numbers, Chain of custody forms (original + copies)
• □ Both parties sign chain of custody form
• □ Record custody transfer time and date
• □ Provide patient with: Courier contact info, Tracking information (if available), Expected delivery timeframe
• □ Notify destination clinic: "Embryos released to courier at [TIME]"

Communication Protocol:

• □ Document pickup completion in patient record
• □ Email confirmation to patient within 2 hours of pickup
• □ Provide patient with tracking link (if available)
• □ Check in with courier at midpoint of transport (for cross-country)
• □ Be available by phone for any courier questions

After Delivery:

• □ Receive confirmation call/email from destination clinic
• □ Request verification: Temperature logs maintained, Inventory matches records, No damage to embryos
• □ Obtain signed chain of custody form from destination
• □ Contact patient to confirm successful delivery
• □ Document delivery confirmation in patient record
• □ Close out transport case in tracking system

If courier is >30 minutes late:

1. Contact courier immediately by phone
2. Contact patient to provide update
3. If courier cannot arrive same day: Reschedule, notify destination clinic, keep embryos in secure storage
4. Document incident and resolution

If consent forms are incomplete:

1. Do NOT release embryos until all forms are complete
2. Contact patient immediately to resolve
3. If patient unavailable: Reschedule pickup for next business day
4. Email/fax missing forms to patient for immediate signature

If physical embryos don't match records:

1. STOP pickup process immediately
2. Senior embryologist and lab director investigate
3. Do NOT release until discrepancy resolved
4. Contact patient with transparent explanation
5. Document incident per clinic's adverse event protocol

If destination clinic won't accept embryos:

1. Courier contacts your clinic immediately
2. Your clinic contacts destination clinic to resolve
3. If unresolvable: Courier returns embryos to your clinic (patient pays return transport)
4. Patient works with new destination clinic
5. Reschedule transport when new clinic confirmed

✓ Need Help Implementing This SOP? GuardianCryo provides staff training, form templates, and ongoing support for clinics developing out-of-area patient programs. Request implementation consultation or call +1 (281) 699-3321.